Thank you to the 88 organizations that joined us to urge the FDA to re-classify female condoms as a Class II device and remove unnecessary barriers to female condom innovation.
June 26, 2015
Division of Dockets Management (HFA–305)
Food and Drug Administration
5630 Fishers Lane, Room1061
Rockville, MD 20852
Re: Down-classification of female condoms
Dear Division of Dockets Management,
The undersigned 89 organizations respectfully submit this statement in response to the Center for Devices and Radiological Health’s (CDRH) request for comments (Federal Register Docket No. FDA-2014-D-0090) regarding its recommendation for the U.S. Food and Drug Administration (USFDA) to consider down-classification of female condoms (procode MBU: Condom, female, single-use).
As organizations working to improve the sexual and reproductive health and rights of individuals both in the United States and globally, we applaud the USFDA’s decision to review current evidence on female condoms, and we strongly recommend down-classification of this important public health tool. Reclassifying female condoms from a Class III to a Class II medical device will likely open the U.S. market to new products, and expand women’s and men’s options for protection from sexually transmitted infections (STIs), including HIV, and unintended pregnancy. Female condoms are the only woman-initiated tool that offers this type of multipurpose protection. This recommended reclassification will also reflect the latest evidence regarding the safety and effectiveness of female condoms, and harmonize the U.S. regulatory system with other regulatory bodies.
The female condom product category has significantly evolved since the USFDA first reviewed the FC1 female condom in 1993. At that time, the FDA determined female condoms should be a Class III medical device since the potential failure modes were determined to be significantly different than male condoms and clinical evidence was available on only one product. In 2008, the FDA reviewed evidence about the FC2 and approved the product in 2009. Numerous studies confirm the safety and performance of the FC2 female condom as well as new female condoms developed during the past decades. International researchers and agencies developed standardized definitions of female condom failure modes, testing standards, and product guidelines to instruct the industry and ensure product quality.
Background
Since the FDA’s 2009 FC2 female condom application review, several important changes in the female condom product category have occurred. The World Health Organization (WHO), UNAIDS, UNFPA, and Family Health International released the WHO/UNFPA Female Condom Generic Specifications, Prequalification and Guidelines for Procurement, 2012. Additionally, the International Organization for Standardization (ISO) Technical Committee ISO/TC 157 published the international standard on female condoms, ISO 25841 in 2012 as well as updated them in 2014. The standard provides essential guidance on specifications and test methods used to verify female condom quality; requires manufacturers to verify the performance and effectiveness of any new or modified female condom design by clinical studies; and requires base product specification on the properties of the condoms used in any clinical performance or effectiveness trial. ISO is currently finalizing a standard to provide guidance on the design, execution, and analysis of clinical trials on female condoms (ISO 29943-2) and male condoms (ISO29943-1). WHO, USFDA, ISO, and field experts support clinical trial guidance and standards for female condoms.
The Female Condom Technical Review Committee, first convened in 2006 by UNFPA and the WHO Department of Reproductive Health and Research (RHR), developed a prequalification scheme that includes review of female condom manufacturers’ technical dossier and a factory audit to assess compliance with the ISO standards for quality systems. The WHO prequalification scheme is designed to ensure that approved female condoms meet a set of predetermined performance, safety, and quality requirements.
While the primary market for female condoms has been in developing countries’ HIV prevention programs, purchasing by the public health sector and individual consumers in the U.S. has steadily increased. The Female Health Company shared via personal communication in December 2013 that U.S. consumer sales increased by more than 40% from 2012 to 2013.
The pipeline of new female condom products is growing in response to consumer interest.1 As new female condom products have been developed, multiple studies confirm the safety and performance of these new female condom products relative to the FC2. A summary of female condom performance and effectiveness across multiple studies shows low failure rates across all female condoms.2 These new products are approved and marketed in other countries where regulatory approval is based on performance and failure mode study data, similar to requirements for approval of male condoms. Yet in the U.S., the FC2 remains the only female condom available. This is largely due to the Class III designation, which poses a significant barrier to other options.
The Class III designation of female condoms in 1993 was intended to ensure safety of a new product category where failure modes were not well characterized, and safety and effectiveness were not well studied. We assert that Class III designation is no longer required for safety, as the product category is well-studied and shown to be safe, and other controls are in place to ensure quality and safety. The USFDA Class III designation serves as a barrier to manufacturers seeking USFDA approval and ultimately negatively impacts women and men who need more prevention options. The high costs associated with a Class III product application prohibit manufacturers from submitting their products for review, thus limiting female condom options in the U.S. to a single product, the FC2. Meanwhile, women and men in other countries are able to access and choose from a number of female condom products to reduce their risk of HIV, STIs, and unintended pregnancy.
Reducing regulatory barriers to approval of new safe and effective female condoms would expand choice and promote individual and public health.1 The evidence base on female condom safety and functionality supports a conclusion that the Class III premarket approval process is no longer needed for new female condoms. Class II special controls, similar to those applied to male condoms, can reasonably be expected to ensure their safety and effectiveness. The evidence to support our request is as follows:
Female condoms are safe.
Twenty years of use data show a good safety record for the FC1/FC2 female condoms. New female condoms have shown to be non-inferior to FC2.2 A recent study of 600 women using four different female condom products indicated non-inferiority for performance for each product.3 The WHO Medical Eligibility Guidelines for Contraceptive Use lists female condoms as a Category One, a product that can be used by any client.4 The 2010 Centers for Disease Control and Prevention (CDC) Medical Eligibility Criteria for Contraceptive Use, adapted from the WHO Guideline, concurs with this recommendation. The Family Planning: Global Handbook for Providers, written by the U.S. Agency for International Development (USAID), WHO, and Johns Hopkins University, states that there are no adverse side effects and no known health risks associated with using female condoms. Latex and synthetic latex female condoms are made by a dipping process that is very similar to the method used for that of male latex condoms and medical gloves, products with a long safety history. Additionally, a January 2015 search of FDA’s Manufacturer and User Facility Device Experience (MAUDE) database from January 1, 1994 through December 31, 2014 resulted in only one report of an adverse event related to the FC1 and none for the FC2.
Female condoms perform well.
Millions of women and men have used female condoms (primarily the FC1/FC2 female condom) since FDA approval 20 years ago. Clinical data show that female condoms have low failure rates.5 Qualitative data indicate that women are better able to negotiate safer sex practices when female condoms are available.6 Such ability is of critical importance to women’s health, particularly in contexts where male condom use is not possible. Female condoms offer women a unique and important prevention option. Studies also demonstrate the total number of protected sex acts increases when female condoms are made available to couples alongside male condoms.7-10
Female condoms are effective.
Three studies examining protection offered against pregnancy by the female condom indicate it is an effective contraceptive.11-13 Together these trials indicate that perfect use of female condoms offer between .08% and 9.5% probability of pregnancy. Data from these studies indicate that typical use of female condoms results in 3.2% to 22.2% probability of pregnancy. Research also demonstrates that female condoms offer effectiveness for reducing women’s risk of STIs comparable to that of male condoms. 14-16
Standard definitions, testing procedures, and guidance exist and are accepted.
International researchers, WHO, and UNFPA developed, published, and adopted standardized definitions of performance that are now widely known and consistently used by researchers evaluating the safety and performance (functionality) of female condom products.17-18 These standardized definitions allow comparison across products and across clinical studies. The table below illustrates outcomes found in one non-inferiority cross-over trial published by Beksinska, et al. in 2013.5
| Female Condom Product | FC2 | Cupid | Woman’s Condom | VA wow |
| Total Condom Failure | 3.43% | 4.52% | 3.85% | 3.02% |
| Total Clinical Failure | 2.88% | 3.87% | 3.05% | 2.49% |
Standard product guidelines for testing laboratories established by the ISO now exist to ensure female condom product quality. As previously mentioned, UNFPA/WHO developed a WHO prequalification scheme to ensure that female condoms considered by international procurement agencies meet international specifications for clinical performance, design, and packaging.
Leading health authorities recognize that female condoms meet a public health need.
WHO and USAID recommend counseling about and access to female and male condoms for family planning clients who are also at risk of HIV. Additionally, the U.S. government is one of the largest donor procurers of female condoms worldwide, and the President’s Emergency Plan for AIDS Relief (PEPFAR) identifies female condoms as “unique in providing a female-controlled HIV prevention option.” The CDC cites condom distribution programs as effective interventions for reducing HIV and STIs.
STI and HIV infections underscore the imperative for more preventative options. HIV and STI rates in the U.S. and around the world illustrate the need for a wider array of tools for people of all genders and sexual orientations. The WHO estimates 2.1 million HIV infections occurred in 2013. Young people account for approximately one-third of these new infections globally. Young women and gay men and other men who have sex with men experience higher rates of HIV infection. CDC HIV surveillance data indicate a modest decline in HIV infections among U.S. women.19 The 2013 HIV Surveillance Report cites increases in new cases among gay men and other men who have sex with men, with young African-American gay men representing the majority of new infections.19 Continuing a positive downward trend among women and reducing the HIV infection burden among gay men requires expanding access to current prevention tools and paving the way for new ones. The 2013 CDC STD Surveillance Report shows that young people comprise nearly half of the U.S.’s new 20 million STIs.20 African-American women (15-29 years of age) bear a disproportionate number of the country’s chlamydia infections. Gonorrhea rates among young women (ages 15-24) are more than 1,000 per 100,000 people.20 While chlamydia and gonorrhea can be cured, they can lead to serious health concerns for women, including pelvic inflammatory disease, ectopic pregnancy and infertility if they go undetected and untreated.
Conclusion
For each of these reasons, we urge the USFDA to change the classification of female condoms from Class III to Class II. Please direct any questions regarding these comments or requests for additional information to National Female Condom Coalition secretariat Jessica Terlikowski at (312) 334-0931 or [email protected].
Sincerely,
ABCD Health Services
Act for Change
Affirmative Action
African Alliance for HIV Prevention
AIDS Alabama
AIDS Foundation Houston, Inc.
AIDS Foundation of Chicago
AIDS Project Los Angeles
AIDS United
AIDSNET
ALPHA Pittsburgh, Inc.
American Academy of HIV Medicine
American College of Obstetricians and Gynecologists
American Sexual Health Association
Ann & Robert H. Lurie Children’s Hospital of Chicago
Anova Health Institute
APLA Health & Wellness
AVAC
BOOM!Health
California Communities United Institute
Care 2 Prevent at the University of Chicago
Cascade AIDS Project
Center for Health and Gender Equity
Center for Women Policy Studies
Chicago Female Condom Campaign
Chicago Recovery Alliance
Chicago Women’s AIDS Project
CUPID LIMITED
Deborah’s Place
Desmond Tutu HIV Foundation
DUH and Healthcare Justice March
END AIDS NOW
Fenway Health
Femmes-Santé-Développement (FESADE)
Gender Care Initiative
Global Justice Institute, Metropolitan Community Churches
Harlem United
Health and Opportunity Network
HIV Prevention Justice Alliance
HIVE
HLL Lifecare Limited
Hope for the Generation Organization
House of Blahnik, Inc.
HPV Awakening Inc.
Hyacinth AIDS Foundation
Ibis Reproductive Health
Illinois Caucus for Adolescent Health
International Community of Women Living with HIV AIDS
International Rectal Microbicide Advocates
ISA Associates
Kids & Teens Resource Centre
Knew Choices Inc.
MatCH Research
Men in Health
Minnesota AIDS Project
National Alliance of State & Territorial AIDS Directors
National Center for Lesbian Rights
National Coalition for LGBT Health
National Coalition of STD Directors
National Female Condom Coalition
National Organization for Women
National Women’s Health Network
Nebraska AIDS Project
Ngo Hygie-Enwerem Foundation
Open Aid Alliance
Oregon Foundation for Reproductive Health
ORIGAMI Healthcare Products Inc.
PATH
Pathfinder International
Pediatric AIDS Chicago Prevention Initiative
PeterCares House
Planned Parenthood Gulf Coast
Planned Parenthood Gulf Coast, Inc.
Planned Parenthood of Illinois
Positive Women’s Network – USA
Project Inform
Reproductive Health Technologies Project
Rutgers
San Antonio AIDS Foundation
San Francisco AIDS Foundation
SisterLove, Inc.
Test Positive Aware Network
The 30 for 30 Campaign
The Eagle Eye Behavioral Reorientation Initiative (TEEBRI)
The Well Project
Turning Point of Central California
Universal Condom L.A.
Women Organized to Respond to Life-threatening Diseases (WORLD)
Women With A Vision
____________________
1. Beksinska, M.E., Smit, J., Joanis, C., & Potter, W. (2012). New female condoms in the pipeline. Reproductive Health Matters, 20(40):186-196.
2. Gallo, M.F., Kilbourne-Brook, M., & Coffey, P.S (2012). A review of the effectiveness and acceptability of the female condom for dual protection. Sexual Health, http://dx.doi.org/10.1071/SH11037.
.3 Beksinska, M.E., Piaggio, G., Smit, J.A., Wu, J., Zhang, Y., Pienaar, J.; Greener, R., Zhou, Y. & Joanis, C. (2013). Performance and safety of the second-generation female condom (FC2) versus the Woman’s, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial. Lancet Global Health, 1 (e), 146-152.
4. WHO Medical Eligibility Guidelines for Contraceptive Use, 4th edition, (2009) http://whqlibdoc.who.int/publications/2010/9789241563888_eng.pdf?ua=1
5. Beksinska, M.E., Piaggio, G., Smit, J.A., Wu, J., Zhang, Y., Pienaar, J.; Greener, R., Zhou, Y. & Joanis, C. (2013). Performance and safety of the second-generation female condom (FC2) versus the Woman’s, the VA worn-of-women, and the Cupid female condoms: a randomised controlled non-inferiority crossover trial. Lancet Global Health, 1 (e), 146-152.
6. Hatzell, T., & Feldblum, P. J. (2003). The female condom: Is “just as good” good enough? Sexually Transmitted Diseases, 440-442.
7. Barbosa, R.M., Kalckmann, S., Berquó, E., & Stein, Z. (2007). Notes on the female condom: Experiences in Brazil. International Journal of STD and AIDS, 18(4): 261-266.
8. Hoke TH., Feldblum, P.J., Van Damme, K., Nasution, M.D., Grey, T.W., Wong, E.L., Ralimamonjy, L., Raharimalala, L., & Rasamindrakotroka, A. (2007). Randomised controlled trial of alternative male and female condom promotion strategies targeting sex workers in Madagascar. Sexually Transmitted Infections, 83(6): 448-453.
9. Choi, K., Hoff, C., Gregorich, S.E., Grinstead, O., Gomez, C., & Hussey, W. (2008). The efficacy of female condom skills training in HIV risk reduction among women: A randomized controlled trial. American Journal of Public Health, 98(10), 1841-1848.
10. Vijayakumar G, Mabude Z, Smit J,Beksinska M, Lurie M. A Review of the impact of the female condom on proportion of protected sex acts and STI incidence. International Journal of STD and AIDS. 2006; 17(10):652-659.
11. Bounds, W., Guillebaud, J., & Newman, G.B., (1992) Female condom (Femidom): a clinical study of its use-effectiveness and patient acceptability. British Journal of Family Planning Fam Plann 1992; 18: 36–41.
12. Farr, G., Gabelnick, H., Sturgen, K., & Dorflinger, L. (1994). Contraceptive efficacy and acceptability of the female condom. American Journal of Public Health 1, 84, 1960–1964.
13. Trussell, J (1998). Contraceptive efficacy of the Reality female condom. Contraception, 58: 147–148.
14.French, P.P., Latka, M., Gollub, E.L., Rogers, C., Hoover, D.R.,& Stein, Z.A. (2003). Use-effectiveness of the female versus male condom in preventing sexually transmitted disease in women. Sexually Transmitted Diseases, 30(5):433–439.
15. Fontanet, A.L., Fontanet AL1, Saba J, Chandelying V, Sakondhavat C, Bhiraleus, P., Rugpao, S., Chongsomchai, C., Kiriwat, O., Tovanabutra, S., Dally, L., Lange, J.M., & Rojanapithayakorn, W. (1998). Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial. AIDS, 12(14):1851–1859.
16. Feldblum PJ et al. (2001). Female condom introduction and sexually transmitted infection prevalence: results of a community intervention trial in Kenya. AIDS, 15(8):1037–1044.
17. Bksinska, M.E., Joanis, C., Manning, J., Smit, J., Callahan, M., Deperthes, B., & Usher-Patel, M. (2007). Standardized definitions of failure modes for female condoms. Contraception, 75, 251– 255.
18. Beksinska, M.E., Smit, J., Joanis, C., & Potter, W. (2012). New female condoms in the pipeline. Reproductive Health Matters, 20(40):186-196.
19. Centers for Disease Control and Prevention. HIV Surveillance Report, 2013; vol. 25. http://www.cdc.gov/hiv/library/reports/surveillance/. Published February 2015. Accessed May 25, 2015.
20. Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2013. Atlanta: U.S. Department of Health and Human Services; 2014.